Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

March 18, 2024 updated by: University of Alabama, Tuscaloosa

Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study

Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study will be conducted as a single blind, randomized crossover design with a 4-week arm (placebo or control) followed by a 2-week washout period and another 4-week arm (placebo or control).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristi M Crowe-White, PhD, RD
  • Phone Number: 205-348-6173
  • Email: kcrowe@ches.ua.edu

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35487
        • Recruiting
        • The University of Alabama
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2

Exclusion Criteria:

  • Dx - Diagnosis of cardiovascular disease, type 1 or 2 diabetes, liver disease, cancer, endocrine disorders, or inflammatory condition such as rheumatoid arthritis.
  • GI - History of gastrointestinal surgery, irritable bowel syndrome, intestinal bowel disease, or other gastrointestinal distress such as chronic diarrhea, bulimia, anorexia, or frequent laxative use
  • Rx or Supplements - Actively taking steroids or antibiotics in the previous two to three months, or currently using tobacco products, > 10% weight loss or gain in the last 6 months, unwilling to stop taking prebiotic/probiotic or fiber supplements
  • Dietary - Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm - Yogurt with added Spices
Consumption of twice daily yogurt with added spices for four weeks.
Other: Yogurt with added Spices
Consumption of twice daily yogurt with added spices for four weeks.
Sham Comparator: Sham Arm - Yogurt without added Spices
Consumption of twice daily yogurt without added spices for four weeks.
Other: Yogurt without added Spices
Consumption of twice daily yogurt without added spices for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
Time Frame: pre/post each four-week study arm
Units - uM
pre/post each four-week study arm
Concentration of serum leptin
Time Frame: pre/post each four-week study arm
Units - ng/mL
pre/post each four-week study arm
Concentration of serum ghrelin (pg/mL)
Time Frame: pre/post each four-week study arm
Units - pg/mL
pre/post each four-week study arm
Concentration of serum peptide tyrosine tyrosine (PYY)
Time Frame: pre/post each four-week study arm
Units - pg/mL
pre/post each four-week study arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama, Tuscaloosa

Collaborators

McCormick Science Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-1055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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